Director - New Product Introduction and Lifecycle
vor 3 Wochen
Cilag AG, a member of the Johnson & Johnson Family of Companies since 1959, is recruiting for a Director - New Product Introduction and Lifecycle Management (NPI & LCM)
The Schaffhausen site acts as one of the major producers of the Swiss pharmaceutical industry and one of the most important employers in the Schaffhausen region. It is a centre for launching and boosting growth in parenterals. Cilag AG Schaffhausen produces high-quality pharmaceutical substances and products, from which patients benefit all over the world.
The Director - NPI & LCM is responsible for leading a team ensuring the successful introduction and launch of new products into our aseptic pharmaceutical manufacturing environment. The Director will also be responsible for the lifecycle management of new and already mature products. They ensure safety, quality, and compliance and also champion a culture of continuous improvement, people development, and inclusivity. Their efforts will contribute to J&J's commitment to both operational excellence and the growth and well-being of a diverse workforce.
**Key Responsibilities**:
- Direct managers and senior individual contributors in a dynamic environment, ensuring that project plans are comprehensively reviewed, implemented, and completed on schedule and within budget.
- Develop and implement a comprehensive strategy for the introduction of new products in close collaboration with Research and Development, Operations, Quality Functions, Value Chain Management, and Manufacturing Scient and Technology (MSAT).
- Collaborate closely with internal and external partners, including suppliers, contract manufacturers, and regulatory authorities, to ensure timely and successful product introductions and lifecycle management.
- Lead all aspects of the entire product lifecycle, from development and introduction to post-market surveillance and phase-out, ensuring compliance with regulatory requirements and quality standards.
- Find opportunities for process optimization and continuous improvement in product development and introduction processes.
- Create, maintain, and upgrade product technical knowledge and support the overall Value Chain (VC) knowledge infrastructure.
- Support Drug Product process transfers between manufacturing sites (internal or external).
- Serve as Technology Champion within the domain of parenteral production.
- Participate in technical, quality, and compliance risk assessments and develop mitigation strategies and possible BCP options.
- Support inspection readiness and support non-conformance and failure investigations.
- Participate and present at industry-related conferences and seminars.
**Qualifications**:
**Education**:
- Minimum of a Bachelor's/University or equivalent degree in Pharmacy, Chemistry, Biotechnology, or an equivalent scientific field is required; M.S./ PhD preferred
**Experience and Skills**:
**Required**:
- Minimum 10 years of relevant work experience
- Experience with New Product Introduction into the pharmaceutical manufacturing environment
- Thorough knowledge of regulatory requirements and quality standards in the pharmaceutical industry
- People management or leadership experience (direct or indirect reports)
- Strong communication skills to effectively motivate and lead interdisciplinary teams and interact at various levels of the organization, including senior management
- Strong creative and analytical thinking skills and a track record of developing innovative solutions for complex challenges
- Demonstrated mentality to recognize opportunities, a willingness to take calculated risks, and the ability to encourage ambitious thinking
**Preferred**:
- Lean, Six Sigma, or Process Excellence methodologies experience, training, or certification
- Experience supporting inspections or audits
**Other**:
- Requires proficiency in both English and German (written and spoken); additional language skills are a plus
- May require up to 10% domestic and international travel
- Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
**_Why join Johnson & Johnson _**
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